Annual Cost and Effects of Switching to Insulin Degludec from Other Basal Insulins: Evidence from Swedish Real-World Data

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6

to surgery, following failed surgery or while awaiting the benefit of radiotherapy. The objective of the present study was to evaluate the cost-effectiveness of ketoconazole versus metyrapone for the treatment of CS.  Methods: The analyses were performed in a simple Markov model with health states describing the management and control of primarily Cushing’s disease (CD) patients (a subset of CS) in terms of uncontrolled or controlled disease as measured by the level of urinary free cortisol. The societal and the payer perspective for a time horizon of three years were applied for base-case analyses.  Results: The results from the societal as well as payer perspective indicated that ketoconazole was dominant as compared to metyrapone for the treatment of CS in Sweden, offering limited cost-savings (€  190) and a small QALY gain (0.001 QALYs). The estimated cost-savings and QALY gain were, however, very limited and it is more reasonable to assume similar costs and equal effectiveness for the two treatments compared. The results were maintained in one-way sensitivity analyses (±25% of base-case).  Conclusions: In the present analyses ketoconazole was estimated to have similar costs and effectiveness as compared to metyrapone. The results of the performed analyses subsequently resulted in the inclusion of ketoconazole in the Swedish reimbursement system. As both drugs are now reimbursed in Sweden, physicians thus have the choice to individually adapt the treatment to each patient as necessary, without any cost constraints. PDB46 Cost-Effectiveness of Empagliflozin (Jardiance) in the Treatment of Patients with Type 2 Diabetes Mellitus (T2DM) in the UK Based on Empa-Reg Outcome Data Daacke I1, Kandaswamy P2, Tebboth A3, Kansal A4, Reifsnider O4 1Boehringer Ingelheim, Bracknell, UK, 2Boehringer Ingelheim GmbH, Ingelheim, Germany, 3Boehringer Ingelheim UK, Bracknell, UK, 4Evidera, Bethesda, MD, USA

Objectives: The EMPA-REG OUTCOME trial was a randomised, double-blind, placebo-controlled, cardiovascular (CV) safety trial which examined the long-term effects of empagliflozin versus placebo, in addition to standard of care (SoC), on CV morbidity and mortality in patients with T2DM and a high risk of CV events. Empagliflozin showed 38% reduction in CV death (95% CI: 0.49-0.77, p< 0.001) and a 35% reduction in hospitalisation for heart failure (95% CI: 0.50-0.85, p= 0.002). A posthoc analysis showed a 39% reduction in nephropathy (95% CI: 0.53-0.70, p< 0.001) and a 55% reduction in renal replacement therapy (95% CI: 0.21-0.97, p= 0.04). The objective was to  quantify the clinical and economic outcomes of empagliflozin for treatment of patients with T2DM at increased CV risk based on the EMPA-REG OUTCOME™ study.  Methods: An economic model was created to simulate profiles of patients treated with empagliflozin versus patients treated with placebo, both added to SoC, over a lifetime horizon. Time-dependent survival regression analysis was performed on the EMPA REG OUTCOMES trial data to model event rates over time and the interaction between events. Model outcomes included costs incurred, life years (LY) and quality-adjusted life-years (QALYs). Future costs and QALYs were discounted at a 3.5% annual rate.  Results: Empagliflozin was predicted to result in longer survival (15.0 LY vs. 13.0 LY with SoC). This was attributable to both a direct treatment effect on CV mortality and an indirect effect via reductions in other CV events, particularly heart failure hospitalisation. This results in a predicted 0.9 incremental QALYs with empagliflozin at an incremental cost of £3,971 per patient and an incremental cost-effectiveness ratio of £4,365/QALY. This is well below the common threshold for cost-effectiveness in the UK (£20,000/QALY).  Conclusions: Empagliflozin is a cost-effective option for the treatment of T2DM patients at a high risk of CV events. PDB47 Cost-Effectiveness Analysis of Insulin Degludec Compared with Insulin Glargine in the Management of Type 1 and Type 2 Diabetes Mellitus from the Spanish National Health System Perspective Ramirez de Arellano A1, Mezquita P2, Darba J3 1Novo Nordisk, Madrid, Spain, 2Hospital Torrecardenas, Almeria, Spain, 3Universitat de Barcelona, Barcelona, Spain

Objectives: The objective of this study was to assess the cost-effectiveness of once-daily insulin degludec (IDeg) versus once-daily insulin glargine (IGlar) in three groups of patients: 1) patients with type 1 diabetes (T1DM); 2) patients with type 2 diabetes (T2DM) treated with basal only therapy insulin in combination with oral anti-diabetics (BOT); and 3) patients with T2DM treated with basal-bolus (B/B) insulin. The perspective is that of the Spanish NHS.  Methods: Two utility approaches were used to estimate effectiveness. 1) The SF-36 cost-effectiveness model uses quality of life results derived from the clinical trials for each treatment arm. 2) The event disutility model estimates effectiveness results in terms of number of adverse events (hypoglycaemic events derived from clinical trials) and their disutility impact throughout the year on the initial level of quality of life for patients in each treatment arm. Costs and utilities were also calculated for potential use of fewer blood glucose test strips in the case of degludec. Unit costs pertained to public tariffs and reflected the payer perspective. Baseline incidence rates of hypoglycaemia and related resource use were derived from a Spanish observational study.  Results: IDeg was the dominant strategy for T2DM BOT. IDeg exhibits an ICER of 49.50€ /QALY and 12,418€ /QALY for T1DM B/B and T2DM BB, respectively. The use of the two utility methods gave similar results. Univariate and probabilistic sensitivity analyses confirmed the robustness of the results.  Conclusions: This analysis demonstrates that IDeg is a cost-effective option in the Spanish NHS, when used in patients currently treated with longacting insulin. PDB48 Annual Cost and Effects of Switching to Insulin Degludec from Other Basal Insulins: Evidence from Swedish Real-World Data Gundgaard J1, Landstedt-Hallin L2, Ericsson Å3, Ellfors-Zetterlund S3 Nordisk A/S, Søborg, Denmark, 2Danderyd Hospital, Stockholm, Sweden, 3Novo Nordisk

1Novo

A673

Scandinavia AB, Malmö, Sweden

Objectives: To conduct an economic analysis to assess the short-term costeffectiveness of insulin degludec (IDeg) after switching from other basal insulins in type 1 diabetes in a real-life practice setting.  Methods: This was a prospective, single-arm, observational follow-up of 476 consecutive patients at Danderyd Hospital who switched to IDeg from their previous basal insulin. A short-term model was used to predict the cost-effectiveness of annual treatment with IDeg vs. other basal insulins, based on a Swedish setting. The long-term impact of HbA1c was modelled previously.  Results: Mean (SD) duration of diabetes was 22.5 (14.2) years and duration of follow-up was 21.7 (6.0) weeks. The frequency of hypoglycaemia during the 4 weeks prior to end of follow-up vs. the 4-week period immediately prior to switching decreased by 12% (p= 0.0127) for non-severe daytime events and by 53% (p< 0.0001) for non-severe nocturnal events. Severe hypoglycaemia was reduced by 62% (p= 0.0225) during comparator periods of 4 months immediately prior to switching and prior to the end of follow-up. Mean insulin doses decreased by 13.1% (p< 0.001) for basal insulin and 7.5% (p< 0.001) for bolus insulin. The model estimated a gain of 0.03 quality-adjusted life years (QALYs) due to fewer non-severe and severe hypoglycaemic events, and savings in health care costs of SEK 802 annually. Including indirect costs savings amounted to SEK 1019. Both from a health care (direct costs) and a societal perspective (direct and indirect costs) the incremental Cost-Effectiveness Ratio (ICER) showed IDeg was dominant compared to other basal insulins (i.e. higher effectiveness at lower cost). IDeg was also dominant for a subgroup of patients with repeated hypoglycaemia/ unstable glucose with and without the inclusion of indirect costs.  Conclusions: This short-term CEA suggests that switching to IDeg from other basal insulins is a cost-saving option already from year one, even when excluding the long-term impact of reduction in HbA1c. PDB49 Evaluating the Cost-Effectiveness of Liraglutide 1.8Mg Versus Lixisenatide 20μ g for the Treatment of Type 2 Diabetes Mellitus in the Spanish Setting Kragh N1, Ye E1, Hunt B2, Valentine WJ2 1Novo Nordisk A/S, Søborg, Denmark, 2Ossian Health Economics and Communications, Basel, Switzerland

Objectives: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are associated with improved glycemic control, weight loss and low risk of hypoglycemia when used to treat patients with type 2 diabetes mellitus. The aim of the present analysis was to compare the long-term cost-effectiveness of liraglutide 1.8mg and lixisenatide 20μ g, two GLP-1 RAs, both administered once daily in patients with type 2 diabetes failing to achieve glycemic control on metformin monotherapy in Spain. Methods: Projections of lifetime costs and clinical outcomes were made using the IMS CORE Diabetes Model. The baseline cohort and treatment effects applied in the first year of the analysis were based on the LIRA-LIXITM trial (NCT01973231), a 26-week, parallel group, open-label study comparing liraglutide 1.8mg with lixisenatide in patients with type 2 diabetes failing to achieve glycemic control on metformin monotherapy. Costs were accounted in 2015 EUR, and future costs and clinical benefits were discounted at 3% annually. Sensitivity analyses were performed.  Results: Modeled projections suggested that liraglutide 1.8mg was associated with improved discounted life expectancy (14.42 versus 14.29 years) and discounted quality-adjusted life expectancy (9.40 versus 9.26 quality-adjusted life years [QALYs]) compared with lixisenatide. Benefits were driven by improved glycemic control, which led to a reduced incidence and delayed time to onset of diabetes-related complications. Liraglutide 1.8mg was associated with increased total costs over patient lifetimes (EUR 42,689 versus EUR 42,143) due to higher acquisition costs, but this was partially offset by lower costs of treating diabetes-related complications (EUR 29,613 versus EUR 30,636). Liraglutide 1.8mg was associated with an incremental cost-effectiveness ratio of EUR 4,113 per QALY gained versus lixisenatide.  Conclusions: Long-term projections suggest that, in the Spanish setting, treatment of patients with type 2 diabetes failing to achieve glycemic control on metformin monotherapy with liraglutide 1.8mg is likely to be considered costeffective compared with lixisenatide therapy. PDB50 Cost-Effectiveness and Cost-Utility of Intralesional Recombinant Human Epidermal Growth Factor for Adjuvant Treatment of Wagner’s 3 and 4 Diabetic Foot Ulcers Romero Prada ME1, Vivas-Consuelo D2, Huerfano LM3, Alfonso Quiñones PA4, Roa Cardenas NC3, Acero G4 1Fundación Salutia, Bogotá, Colombia, 2Universitat Politècnica de València (UPV), Valencia, Spain, 3Salutia Foundation - Research center in economy, management and health technologies., Bogota, Colombia, 4Salutia Foundation, Bogotá, Colombia

Objectives: assess cost effectiveness and cost utility of the use of recombinant intra and perilesional recombinant human epidermal growth factor as adjuvant treatment against standard therapy on patients with Wagner’s 3 or 4 diabetic foot ulcers in Colombia.  Methods: using a Markov model the cost effectiveness relations were identified from the addition of the recombinant human epidermal growth factor to conventional therapy compered to conventional therapy without other treatment on a hypothetical cohort of 100 patients with Wagner’s 3 or 4 diabetic foot ulcers. The model was developed with monthly cycles, on a 5 year time horizon, from the perspective of the paying agent. Effectiveness data were taken from literature, which showed lack of comparator for this technology. Technology costs were estimated taking into account then Colombian System for Drug Prices, market channel with a 5% discount rate. As outcomes, were taken the number of avoided amputations, disability adjusted life years, quality adjusted life years and total treatment costs.  Results: on a five years temporal horizon with market cost of the assessed technology, 22,09 amputations were presented, against 55.78 from standard therapy, which represents 33,69 amputations less with the use of